Autonomic Recalibration

NCT06603168 | Completed

• 1 other identifier: 2022-058
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if Autonomic Recalibration works to reduce sympathetic dominance to alleviate dysfunctional myofascial pain. The main questions it aims to answer are: How is the Autonomic Nervous System (ANS) affected during Autonomic Recalibration Treatment (ART)? How are myofascial tissue properties impacted from ART? Participants will: Have 2 treatments of ART on consecutive days. Wear sensors to track HRV (heart rate variability) and GSR to verify autonomic recalibration. Measure changes in range of motion by wearing a Rokoko motion capture suit. Measure changes in muscle stiffness through shear wave elastography.

Conditions

Chronic Pain (Back / Neck); Autonomic Dysregulation

Keywords

chronic pain; autonomic nervous system; sympathetic dominance; myofascial pain; Sympathetic tone; dysfunctional pain; Primal Reflex Release Technique; shear wave elastography; heart rate variability; galvanic skin response; Rokoko; motion capture; range of motion; posture

Outcome Measures

Primary Outcomes (6)

• Pain Intensity (NRS Pain Scale)

  0-10 Pain Rating. 0=no pain to 10=pain as intense as you can imagine

  Pre/Post for each day of treatment. 2 days total.

• Heart Rate Variability

  Changes in HRV (ms) pre/post and Day 1/Day 2.

  Pre/Post for each day of treatment. 2 days total.

• Galvanic Skin Response (GSR)

  Comparison of GSR peak counts pre/post and Day 1/Day 2.

  Pre/Post for each day of treatment. 2 days total.

• Muscle Stiffness using Shear Wave Elastography

  Changes in muscle stiffness (kPa) measured by Ultrasound.

  Pre/Post for each day of treatment. 2 days total.

• Nociceptive Trigger Points

  Log of reported trigger points during nociceptive start exam. Taken Pre, Middle, and Post ART on Day 1 and Day 2.

  Pre/Middle/Post for each day of treatment. 2 days total.

• Changes in mobility

  Posture/mobility changes using multivariate morphometric analysis.

  Pre/Post for each day of treatment. 2 days total.

Study Arms (1)

Autonomic Recalibration Treatment

EXPERIMENTAL

Participant receives Autonomic Recalibration Treatment. Measurements: Pre/post shear wave elastography Pre/post myonometry Pre/post motion capture HRV/GSR during ART Pre/post pain ratings Pre/post trigger point log

Other: Autonomic Recalibration Treatment

Interventions

Autonomic Recalibration Treatment OTHER

An initial history to r/o pathology and document a chief complaint relevant to pain is conducted. An initial head to toe assessment of withdrawal or startle reflex behavior in response to palpation is performed to identify trigger points and establish patterns of sympathetic dominance throughout the myofascial system. The pattern of sympathetic dominance (pattern of trigger point) is addressed during treatment by Primal Reflex Release Technique Protocol to inhibit somatic afferent feedback loops and rebalance the autonomic nervous system towards a state of parasympathetic dominance. The absence of a trigger point indicates that the treatment is complete.

Autonomic Recalibration Treatment

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• dysfunctional myofascial pain, i.e., ongoing pain not relevant to an acute perturbation (e.g., recent injury) or known underlying condition (e.g., cancer).

You may not qualify if:

• known skin allergies to gel as found in common cosmetic or household products
• can't make treatment appointments on two consecutive days
• myofascial pain is deemed functional (normal response to acute injury or ongoing pathology)
• lacking a COVID-19 vaccination and a booster shot.

Sponsors & Collaborators

• Edward Via Virginia College of Osteopathic Medicine: lead

Study Sites (1)

Edward Via College of Osteopathic Medicine, Auburn Campus

Auburn, Alabama, 36832, United States

Location

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MeSH Terms

Conditions

Chronic Pain; Primary Dysautonomias

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Autonomic Nervous System Diseases; Nervous System Diseases

Study Officials

• William G Pearson, PhD

  Edward Via College of Osteopathic Medicine, Auburn campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Discipline Chair for Anatomy

Model Details: This pilot study design is a pretest-posttest cohort study.

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: April 27, 2023
• Primary Completion: August 24, 2023
• Study Completion: February 27, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)